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FDA 510(k)

C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG

K-Number: K103122 · 2010-12-30

Decision Date2010-12-30
Product CodeILK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG is the device name listed in this FDA 510(k) record. The listed applicant is Aat Alber Antriebstechnik GmbH. It received FDA 510(k) clearance on 2010-12-30 under 510(k) number K103122. The device is classified under product code ILK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG?

C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG is a medical device that received FDA 510(k) clearance on 2010-12-30. The listed applicant is Aat Alber Antriebstechnik GmbH. The 510(k) number is K103122.

When did C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG receive FDA 510(k) clearance?

C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG received FDA 510(k) clearance on 2010-12-30, under 510(k) number K103122.

Who is the listed applicant for C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG?

The FDA 510(k) record lists Aat Alber Antriebstechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG?

The FDA product code for C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG is ILK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: ILK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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